Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
NCT ID: NCT00426621
Last Updated: 2007-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2006-11-30
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
2
Placebo
4 grams per knee, 4 times per day, for 12 weeks
Interventions
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Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
Placebo
4 grams per knee, 4 times per day, for 12 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
35 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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University of California, in Los Angeles, Division of Rheumatology,
Principal Investigators
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Roy Altman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
Locations
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Coastal Clinical Research Inc
Mobile, Alabama, United States
River Region Research, LLC
Tallassee, Alabama, United States
East Valley Family Physicians
Chandler, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Heartland Research Associates LLC
Arkansas City, Arkansas, United States
Lovelace Scientific Research, Inc.
Beverly Hills, California, United States
MED Investigations
Carmichael, California, United States
MED Investigations, Inc.
Fair Oaks, California, United States
Universal BioPharma Research, Inc.
Fresno, California, United States
Santa Barbara Clinical Research, Inc
Santa Barbara, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Clinical Research Consultants, LLC
Stratford, Connecticut, United States
Seidman Clinical Trials
Delray Beach, Florida, United States
Florida Medical Research Institute
Gainesville, Florida, United States
South Florida Clinical Research Center
Hollywood, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Suncoast Internal Medicine Consultants
Largo, Florida, United States
AppleMed Research, Inc.
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Sunshine Research Center, LLC
Opa-locka, Florida, United States
Peninsula Research, Inc.
Ormond Beach, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Andres Patron DO PA
Pembroke Pines, Florida, United States
Radiant Research - St Petersburg
Pinellas Park, Florida, United States
Sunrise Medical Research
Plantation, Florida, United States
Coastal Medical Research
Port Orange, Florida, United States
Radiant Research
Stuart, Florida, United States
Intermountain Orthopaedics
Boise, Idaho, United States
Medical Specialists Clinical Research Center
Munster, Indiana, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Best Clinical Trial, LLC
New Orleans, Louisiana, United States
Peter A. Holt, MD
Baltimore, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Phase III Clinical Research
Fall River, Massachusetts, United States
Professional Clinical Research, Inc
Cadillac, Michigan, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Internal Medical Associates
Grand Island, Nebraska, United States
South Jersey Medical Associates, PA
Blackwood, New Jersey, United States
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, United States
Rapid Medical Research, Inc
Cleveland, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Radiant Research, Inc. - Akron
Mogadore, Ohio, United States
Clinical Research Source, Inc
Perrysburg, Ohio, United States
Neshaminy Medical, PC
Bensalem, Pennsylvania, United States
Westminster Family Medicine
Erie, Pennsylvania, United States
Feasterville Family Health Care Center
Feasterville, Pennsylvania, United States
Southeastern Pennsylvania Medical Institute
Havertown, Pennsylvania, United States
Radiant Research
Philadelphia, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Radiant Research - Anderson
Anderson, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Walter F. Chase, M.D., P.A.
Austin, Texas, United States
Radiant Research Dallas North
Dallas, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Radiant Research - San Antonio
San Antonio, Texas, United States
Texas Research Center, LLP
Sugar Land, Texas, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
The Physicians Clinic of Spokane
Spokane, Washington, United States
Advanced Healthcare
Milwaukee, Wisconsin, United States
Countries
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References
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Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
Other Identifiers
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VOSG-PN-316
Identifier Type: -
Identifier Source: org_study_id